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OpenTrials
Completed

NCT Number: NCT01450579

A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers

This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyushu, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight: Female: ≥40.0 kg, <70.0 kg, Male: ≥50.0 kg, <80.0 kg
  • BMI: ≥17.6, <26.4
  • Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion criteria

  • Scheduled to receive another vaccine during study period
  • History of H5 influenza infection or received H5 influenza vaccine
  • Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
  • Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
  • Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
  • History of seizures
  • Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Treatment and study plan

ASP7373

Biological

Intermuscular administration

Placebo

Biological

Intramuscular administration

Primary outcomes

  1. Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs

    Time frame: up to 43 days

  2. Immunogenicity (HI antibody titer)- first vaccine

    Time frame: on Day 21

  3. Immunogenicity (HI antibody titer)- second vaccine

    Time frame: on Day 43

    second vaccination on Day 22

Sponsors and collaborators

Lead sponsor

UMN Pharma Inc.

Industry

Registry information

Official study title

Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 12, 2011
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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